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摘要
CONTEXT: Currently, there is limited data on the prevention of chemotherapy-induced nausea and vomiting (CINV) in Indian patients. AIMS: This post hoc study assessed the efficacy and safety of fosaprepitant compared with aprepitant for prevention of CINV in the Indian population. A subgroup analysis was performed from data collected in a phase 3 study of intravenous (IV) fosaprepitant or oral aprepitant, plus the 5-HT3 antagonist ondansetron and the corticosteroid dexamethasone, in cisplatin-nave patients with solid malignancies. MATERIALS AND METHODS: Patients scheduled to receive cisplatin (>= 70 mg/m(2)) were administered a single IV dose of fosaprepitant dimeglumine (150 mg) on day 1 or a 3-day dosing regimen of oral aprepitant (day 1: 125 mg, days 2 and 3: 80 mg) with standard doses of ondansetron and dexamethasone. Patients recorded nausea and/or vomiting episodes and their use of rescue medication and were monitored for adverse events (AEs) and tolerability. STATISTICAL ANALYSIS USED: Differences in response rates between fosaprepitant and aprepitant were calculated using the Miettinen and Nurminen method. RESULTS: In the Indian subpopulation (n = 372), efficacy was similar for patients in both the fosaprepitant or aprepitant groups; complete response in the overall, acute, and delayed phases and no vomiting in all phases were approximately 4 percentage points higher in the fosaprepitant group compared with the aprepitant group. Fosaprepitant was generally well-tolerated; common AEs were similar to oral aprepitant. CONCLUSIONS: IV fosaprepitant is as safe and effective as oral aprepitant in the Indian subpopulation and offers an alternative to the oral formulation.
- 出版日期2013-12
- 单位河北医科大学
